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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Fluid, Non-Electrically Powered
510(k) Number K921797
Device Name PRECI-JET 50
Applicant
Hmi Industries, Inc.
34 Greensboro Dr.
2nd Floor
Rexdale, Ontario,  CA M9W 1E1
Applicant Contact STEVENSON
Correspondent
Hmi Industries, Inc.
34 Greensboro Dr.
2nd Floor
Rexdale, Ontario,  CA M9W 1E1
Correspondent Contact STEVENSON
Regulation Number880.5430
Classification Product Code
KZE  
Date Received04/14/1992
Decision Date 11/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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